Understanding the Requirements of the International MDSAP Audit Approach

Course Duration: 2 Days - 8 Hours/day

This two-day training course covers the requirements of the international Medical Device Single Audit Program (MDSAP) Audit Approach. The focus of this course is solely on the MDSAP Audit Approach, not the ISO 13485 QMS standard. If you are planning to audit conformity to the MDSAP requirements, Omnex also offers both a four-day auditing course as well as a five-day lead auditor course that covers both the requirements and how to audit the regulations for conformity.

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. This course is designed for those that are already experienced and have been trained on ISO 13485. While the linkages to ISO 13485 requirements will be discussed, the 13485 requirements are not covered in depth. This is in line with IMDRF competency and training requirements, which require at a minimum:

  • 40 hours of training in quality management systems (e.g., ISO 9001) including a minimum of 8 hours dedicated to additional medical device quality management system requirements (e.g., ISO 13485)
  • 32 hours of training in medical device regulations and auditing for conformity to these regulations
  • 8 hours training in risk management principles, preferably related to the design of a medical device (e.g., ISO 14971)

Note: Omnex offers further training on both ISO 13485 and ISO 14971. For third-party auditors, check with your Auditing Organization for specific training requirements.

This course provides extensive practical training and hands-on exercises, which will help prepare medical device implementers to identify critical MDSAP requirements.

Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.

This course will help you:

  • Improve understanding of regulatory auditing
  • Improve competence for MDSAP development, implementation and maintenance of a QMS that meet all MDSAP audit requirements
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Learning Objectives

  • Describe MDSAP Background and Acceptability
  • Describe MD-QMS documentation and MDSAP structure
  • Define requirements for Device Marketing
  • Define Measurement, Analysis and Improvement processes
  • Define Medical Device Adverse Event & Advisory Notices Requirements (AEANR)
  • Define MDSAP Design & Development processes
  • Define MDSAP Production and Service Control processes
  • Define MDSAP Purchasing process

Course Outline

Day One

  • Introduction and Welcome
  • MDSAP Background & Acceptability and MDQMS Structure

o Exercise 1: GHTF SG3 Risk Assessment

  • Chapter 1: Management Processes
  • Chapter 2: Device Marketing Processes

o Exercise 2: Audit Scenarios – Management Process and DMAFR

  • Chapter 3: Measurement, Analysis and Improvement (MAI) Processes
  • Chapter 4: Adverse Event & Advisory Notices Requirements (AEANR) Processes

o Exercise 3: Audit Scenarios – Measurement, Analysis and Improvement and AEANR

Day Two

  • Chapter 5: Design & Development Processes

o Exercise 4: Audit Scenarios – Design & Development

  • Chapter 6: Production and Service Controls
  • Chapter 7: Purchasing Process

o Exercise 5: Production and Service Control and Purchasing

  • Understanding MDSAP Audit Model Final Exam

Who Should Attend

This course is designed for medical device professionals within medical device organizations currently active in participating jurisdictions as well as organizations expanding their market reach to jurisdictions participating in MDSAP.

Course Materials

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.


  • Understanding the Requirements of ISO 13485, or equivalent training, must be completed before attending this course.
  • If you have no previous auditing experience, the full ISO 13485 Internal or Lead Auditor Training is strongly recommended.

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